Kalamazoo firm wants to start clinical trials next year on drug to help organ-transplant recipients

KALAMAZOO — Tolera Therapeutics Inc. said this week that it has filed an application with the U.S. Food and Drug Administration for a drug helps people deal with organ transplants.

The Kalamazoo-based drug-discovery startup said its biologic protein is designed to suppress the immune systems of patients who have received organ transplants, which can fail because the body rejects and attacks the organ of another person.

"This action marks an important development milestone as the company continues its drive to address the patient's need for safer and more effective immune suppression therapy," said John Puisis, president and CEO of Tolera. "Current industry practices and pipelines offer limited and incomplete solutions to advance patient care and meet this critical need."

Puisis said that if the FDA accepts the company's application, it expect to begin clinical trials of the drug candidate next year.

Tolera is a spin-off company from the Cleveland Clinic Foundation that was brought to Kalamazoo last year with an investment from the Southwest Michigan First Life Sciences Fund. The $50 million fund requires recipients to set up operations in Kalamazoo.

Tolera has also received funding from Triathlon Medical Venture Partners, Hopen Therapeutics and the Michigan Economic Development Corp.